Restricted usage features for surgical instrument

ABSTRACT

Systems, devices and methods for managing surgical instruments throughout their lifecycle include disabling a usage based device lockout and providing notifications for devices nearing a usage based lockout. A device adaptor connected inline between a surgical instrument and a power source can be configured to alter a device EEPROM to allow for additional device usage despite a usage based lockout. Notifications and user prompts may be displayed requiring a user to acknowledge that a usage based device lockout has occurred in order to avoid an attempt to use an expired device in a future procedure.

PRIORITY

This application is a continuation of U.S. patent application Ser. No.14/951,670, entitled “Restricted Usage Features for SurgicalInstrument,” filed Nov. 25, 2015, and published as U.S. Pat. Pub.2017/0143366 on May 25, 2017, issued as U.S. Pat. No. 10,639,059 on May5, 2020, the entire disclosure of which is incorporated by referenceherein.

BACKGROUND

A variety of surgical instruments include an end effector having a bladeelement that vibrates at ultrasonic frequencies to cut and/or sealtissue (e.g., by denaturing proteins in tissue cells). These instrumentsinclude piezoelectric elements that convert electrical power intoultrasonic vibrations, which are communicated along an acousticwaveguide to the blade element. The precision of cutting and coagulationmay be controlled by the surgeon's technique and adjusting the powerlevel, blade edge, tissue traction and blade pressure.

Examples of ultrasonic surgical instruments include the HARMONIC ACE®Ultrasonic Shears, the HARMONIC WAVE® Ultrasonic Shears, the HARMONICFOCUS® Ultrasonic Shears, and the HARMONIC SYNERGY® Ultrasonic Blades,all by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio. Further examplesof such devices and related concepts are disclosed in U.S. Pat. No.5,322,055, entitled “Clamp Coagulator/Cutting System for UltrasonicSurgical Instruments,” issued Jun. 21, 1994, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 5,873,873, entitled“Ultrasonic Clamp Coagulator Apparatus Having Improved Clamp Mechanism,”issued Feb. 23, 1999, the disclosure of which is incorporated byreference herein; U.S. Pat. No. 5,980,510, entitled “Ultrasonic ClampCoagulator Apparatus Having Improved Clamp Arm Pivot Mount,” filed Oct.10, 1997, the disclosure of which is incorporated by reference herein;U.S. Pat. No. 6,325,811, entitled “Blades with Functional BalanceAsymmetries for use with Ultrasonic Surgical Instruments,” issued Dec.4, 2001, the disclosure of which is incorporated by reference herein;U.S. Pat. No. 6,773,444, entitled “Blades with Functional BalanceAsymmetries for Use with Ultrasonic Surgical Instruments,” issued Aug.10, 2004, the disclosure of which is incorporated by reference herein;and U.S. Pat. No. 6,783,524, entitled “Robotic Surgical Tool withUltrasound Cauterizing and Cutting Instrument,” issued Aug. 31, 2004,the disclosure of which is incorporated by reference herein.

Still further examples of ultrasonic surgical instruments are disclosedin U.S. Pub. No. 2006/0079874, entitled “Tissue Pad for Use with anUltrasonic Surgical Instrument,” published Apr. 13, 2006, now abandoned,the disclosure of which is incorporated by reference herein; U.S. Pub.No. 2007/0191713, entitled “Ultrasonic Device for Cutting andCoagulating,” published Aug. 16, 2007, now abandoned, the disclosure ofwhich is incorporated by reference herein; U.S. Pub. No. 2007/0282333,entitled “Ultrasonic Waveguide and Blade,” published Dec. 6, 2007, nowabandoned, the disclosure of which is incorporated by reference herein;U.S. Pub. No. 2008/0200940, entitled “Ultrasonic Device for Cutting andCoagulating,” published Aug. 21, 2008, now abandoned, the disclosure ofwhich is incorporated by reference herein; U.S. Pub. No. 2009/0105750,entitled “Ergonomic Surgical Instruments,” published Apr. 23, 2009,issued as U.S. Pat. No. 8,623,027 on Jan. 7, 2014, the disclosure ofwhich is incorporated by reference herein; U.S. Pub. No. 2010/0069940,entitled “Ultrasonic Device for Fingertip Control,” published Mar. 18,2010, issued as U.S. Pat. No. 9,023,071, on May 5, 2015, the disclosureof which is incorporated by reference herein; and U.S. Pub. No.2011/0015660, entitled “Rotating Transducer Mount for UltrasonicSurgical Instruments,” published Jan. 20, 2011, issued as U.S. Pat. No.8,461,744 on Jun. 11, 2013, the disclosure of which is incorporated byreference herein; and U.S. Pub. No. 2012/0029546, entitled “UltrasonicSurgical Instrument Blades,” published Feb. 2, 2012, issued as U.S. Pat.No. 8,591,536 on Nov. 26, 2013, the disclosure of which is incorporatedby reference herein.

Some ultrasonic surgical instruments may include an articulating shaftsection. Examples of such ultrasonic surgical instruments are disclosedin U.S. Pub. No. 2014/0005701, entitled “Surgical Instruments withArticulating Shafts,” published Jan. 2, 2014, issued as U.S. Pat. No.9,393,037 on Jul. 19, 2016, the disclosure of which is incorporated byreference herein; and U.S. Pub. No. 2014/0114334, entitled “FlexibleHarmonic Waveguides/Blades for Surgical Instruments,” published Apr. 24,2014, issued as U.S. Pat. No. 9,095,367 on Aug. 4, 2015, the disclosureof which is incorporated by reference herein.

As a result of the critical nature of procedures performed with surgicalinstruments, extremely tight tolerances may be required both for newlymanufactured instruments as well as for reusable instruments that havepreviously been put into service. While a particular surgical instrumentmay meet or exceed a specification at the time of manufacture, itsperformance may degrade after several uses due to normal wear and tear,or due to expansion of parts as a result of heat sterilization betweenuses. While manufacturers of such a product my provide guidelines for anumber of uses before an instrument should be disposed, cost consciousend users may ignore such guidelines and create safety and usage issuesfor end users and patients.

While a variety of systems have been made and used for surgical devicelifecycle management, it is believed that no one prior to theinventor(s) has made or used the technology as described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

It is believed the present invention will be better understood from thefollowing description of certain examples taken in conjunction with theaccompanying drawings, in which like reference numerals identify thesame elements and in which:

FIG. 1 depicts a perspective view of a first exemplary surgicalinstrument;

FIG. 2 depicts a side elevation view of a second exemplary surgicalinstrument;

FIG. 3 depicts a flowchart showing exemplary interfaces displayed by agenerator in response to events;

FIG. 4 depicts a flowchart showing additional exemplary interfacesdisplayed by a generator in response to events;

FIG. 5 depicts a perspective view of an exemplary adaptor;

FIG. 6 depicts a perspective view of an exemplary adaptor shown incontext with connecting components;

FIG. 7 depicts a perspective view of the adaptor of FIG. 6 connectingtwo components;

FIG. 8 depicts a flowchart of an exemplary set of steps that a systemcould perform to modify the operation of a connected surgicalinstrument; and

FIG. 9 depicts a flowchart of an exemplary set of steps that a systemcould perform to notify a user of a depleted surgical instrument.

DETAILED DESCRIPTION

The following description of certain examples of the technology shouldnot be used to limit its scope. Other examples, features, aspects,embodiments, and advantages of the technology will become apparent tothose skilled in the art from the following description, which is by wayof illustration, one of the best modes contemplated for carrying out thetechnology. As will be realized, the technology described herein iscapable of other different and obvious aspects, all without departingfrom the technology. Accordingly, the drawings and descriptions shouldbe regarded as illustrative in nature and not restrictive.

It is further understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Thefollowing-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those of ordinary skill in the art in view of theteachings herein. Such modifications and variations are intended to beincluded within the scope of the claims.

For clarity of disclosure, the terms “proximal” and “distal” are definedherein relative to a human or robotic operator of the surgicalinstrument. The term “proximal” refers the position of an element closerto the human or robotic operator of the surgical instrument and furtheraway from the surgical end effector of the surgical instrument. The term“distal” refers to the position of an element closer to the surgical endeffector of the surgical instrument and further away from the human orrobotic operator of the surgical instrument.

I. Overview of Exemplary Ultrasonic Surgical Instruments

Turning now to the figures, FIG. 1 shows a perspective view of anexemplary surgical instrument (100). As described therein and as will bedescribed in greater detail below, instrument (100) is operable to cuttissue and seal or weld tissue substantially simultaneously. It shouldalso be understood that instrument (100) may have various structural andfunctional similarities with the HARMONIC SYNERGY® UltrasonicInstrument. Furthermore, instrument (100) may have various structuraland functional similarities with the devices taught in any of the otherreferences that are cited and incorporated by reference herein.

Instrument (100) is configured to be used as a scalpel. As shown in FIG.1 , instrument (100) of this example comprises a handle assembly (104),a shaft assembly (106), and an end effector (108). The proximal end ofinstrument (100) receives and is fitted with an ultrasonic transducerassembly (102) by insertion of ultrasonic transducer assembly (102) intohandle assembly (104). Handle assembly (104) is configured to receiveultrasonic transducer assembly (102) such that ultrasonic transducerassembly (102) may be coupled to an acoustic waveguide (not shown) inshaft assembly (106) by a threaded connection, though any other suitabletype of coupling may be used. As shown in FIG. 1 , instrument (100) maybe coupled with ultrasonic transducer assembly (102) to form a singleunit. Ultrasonic transducer assembly (102) includes a set ofpiezoelectric elements (not shown) that are located proximal to a horn(not shown) of the rigid acoustic waveguide. The piezoelectric discs areoperable to convert electrical power into ultrasonic vibrations, whichare then transmitted along acoustic waveguide, which extends throughshaft assembly (106), to a blade (110) of end effector (108) inaccordance with known configurations and techniques. By way of exampleonly, this portion of the acoustic drivetrain may be configured inaccordance with various teachings of various references that are citedherein.

Blade (110) may be integral with the acoustic waveguide (not shown) andformed as a single unit. In some versions, blade (110) may be connectedto a waveguide by a threaded connection, a welded joint, and/or someother coupling feature(s). The distal end of blade (110) is disposed ator near a longitudinal position corresponding to an anti-node associatedwith ultrasonic vibrations communicated along a waveguide and blade(110) in order to tune the acoustic assembly to a preferred resonantfrequency f_(o) when the acoustic assembly is not loaded by tissue. Whentransducer assembly (102) is energized, the distal end of blade (110) isconfigured to move substantially longitudinally (along the x axis) inthe range of, for example, approximately 10 to 500 microns peak-to-peak,and perhaps in the range of about 20 to about 200 microns, at apredetermined vibrational frequency f_(o) of, for example, 55,500 Hz.The distal end of blade (110) may also vibrate in the y-axis at about 1to about 10 percent of the motion in the x-axis. Of course, movement ofblade (110) when transducer assembly (102) is energized mayalternatively have any other suitable characteristics. When ultrasonicblade (110) is in an activated state (i.e., vibrating ultrasonically),ultrasonic blade (110) is operable to effectively cut through and sealtissue.

Transducer assembly (102) receives electrical power from a generator(112). In particular, transducer assembly (210) is coupled withgenerator (112) via an adaptor (114) and a cable (120) that is connectedto a receptacle assembly (116) of generator (112). Receptacle assembly(116) provides a power and/or data input/output for connecting asurgical instrument (100) to the generator (112). Generator (112) of thepresent example further includes a display (118). Display (118) providesinformation on the generator (112) and any attached surgical instrument(100). In some versions, display (118) further provides controls orinterfaces for allowing a user to change various settings of generator(112). Generator (112) further includes a power source and controlmodule that is configured to provide a power profile to transducerassembly (102) that is particularly suited for the generation ofultrasonic vibrations through transducer assembly (102).

By way of example only, generator (112) may comprise a GEN 11 or GEN 300sold by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio. In addition orin the alternative, generator (112) may be constructed in accordancewith at least some of the teachings of U.S. Pat. No. 8,986,302, entitled“Surgical Generator for Ultrasonic and Electrosurgical Devices,” issuedMar. 24, 2015, the disclosure of which is incorporated by referenceherein. Still other suitable forms that generator (112) may take, aswell as various features and operabilities that generator (112) mayprovide, will be apparent to those of ordinary skill in the art in viewof the teachings herein. Adaptor (114) may also provide widercompatibility between a specific surgical instrument (100) and aspecific receptacle (116) of generator (112); and may also enableadditional functionality as described in further detail below.

FIG. 2 shows a side elevation view of another exemplary surgicalinstrument (200). Instrument (200) is operable to cut tissue and seal orweld tissue substantially simultaneously. It should also be understoodthat instrument (200) may have various structural and functionalsimilarities with the HARMONIC ACE® Ultrasonic Shears. Furthermore,instrument (100) may have various structural and functional similaritieswith the devices taught in any of the other references that are citedand incorporated by reference herein.

Instrument (200) is configured to be used as a shears. Instrument (200)of this example comprises a handle assembly (202), a shaft assembly(212), and an end effector (214). Handle assembly (202) comprises a body(204) including a pistol grip (208) and a pair of buttons (126). Handleassembly (202) also includes a trigger (206) that is pivotable towardand away from pistol grip (208). It should be understood, however, thatvarious other suitable configurations may be used, including but notlimited to a pencil-grip configuration or a scissor-grip configuration.An ultrasonic transducer assembly (210) extends proximally from body(204) of handle assembly (202). Transducer assembly (210) is coupledwith generator (112) via an adaptor (114) and a cable (220) connected toreceptacle assembly (116). Transducer assembly (210) receives electricalpower from generator (112) and converts that power into ultrasonicvibrations through piezoelectric elements. Generator (112) of theexample shown in FIG. 2 is the same as the generator (112) of theexample shown in FIG. 1 . Other suitable forms that generator (112) maytake will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

End effector (214) includes an ultrasonic blade (216) and a pivotingclamp arm (218). Clamp arm (218) is coupled with trigger (206) such thatclamp arm (218) is pivotable toward ultrasonic blade (216) in responseto pivoting of trigger (206) toward pistol grip (208); and such thatclamp arm (218) is pivotable away from ultrasonic blade (216) inresponse to pivoting of trigger (206) away from pistol grip (208).Various suitable ways in which clamp arm (218) may be coupled withtrigger (206) will be apparent to those of ordinary skill in the art inview of the teachings herein.

Blade (216) of the present example is operable to vibrate at ultrasonicfrequencies in order to effectively cut through and seal tissue,particularly when the tissue is being compressed between clamp arm (218)and blade (216). Blade (216) is positioned at the distal end of anacoustic drivetrain. This acoustic drivetrain includes transducerassembly (210) and an acoustic waveguide (not shown). Transducerassembly (210) includes a set of piezoelectric elements (not shown) thatare located proximal to a horn (not shown) of the rigid acousticwaveguide. The piezoelectric discs are operable to convert electricalpower into ultrasonic vibrations, which are then transmitted alongacoustic waveguide, which extends through shaft assembly (212), to blade(216) in accordance with known configurations and techniques. By way ofexample only, this portion of the acoustic drivetrain may be configuredin accordance with the teachings above and/or various teachings ofvarious references that are cited herein. When ultrasonic blade (216) isin an activated state (i.e., vibrating ultrasonically), ultrasonic blade(216) is operable to effectively cut through and seal tissue,particularly when the tissue is being clamped between clamp arm (218)and ultrasonic blade (216).

Instruments (100, 200) shown in FIGS. 1-2 are merely illustrativeexamples of instruments that may be used with a generator (112) and anadaptor (114). By way of example only, either instrument (100, 200) maybe modified and operable in accordance with the teachings of any of thevarious references that are cited herein. Other examples of suitableinstruments will be apparent to those of ordinary skill in the art inview of the teachings herein.

II. Overview of Exemplary Adaptor

FIG. 5 illustrates an adaptor assembly (504) that is configured toconnect a surgical instrument (100, 200) to a generator (112). It shouldbe understood that adaptor assembly (504) is an example of a form thatthe above-described adaptor (114) may take. Adaptor assembly (504)allows connector assemblies having various geometries to be electricallycoupled to a receptacle assembly (116) of a surgical generator (112). Inother words, adaptor assemblies (504) may be used to enable a singlereceptacle assembly (116) to couple with various kinds of surgicalinstruments having various kinds of connector assemblies. In the exampleshown, adaptor assembly (504) is configured to accommodate a surgicalinstrument (100, 200) having a connector assembly (500). Connectorassembly (500) is coupled with a transducer assembly (102, 210) via acable (502). As is to be appreciated, other versions of adaptorassemblies may accommodate surgical instruments having connectorassemblies that are different from those illustrated in FIG. 5 . Itshould also be understood that cable (502) of this example may be viewedas serving as a representation of cables (120, 220) described above.

FIG. 6 illustrates adaptor assembly (504) after adaptor assembly (504)is inserted into receptacle assembly (116) of surgical generator (112)in accordance with one non-limiting example. FIG. 7 illustratesconnector assembly (500) after being inserted into the adaptor assembly(504). Accordingly, a variety of connector assemblies (500), each havingdifferent geometries, may be used with surgical generator (112).

As shown in FIG. 5 , adaptor assembly (504) of the present example has adistal portion (506) that comprises a projection (508). Projection (508)is configured to be inserted into receptacle assembly (116) of thesurgical generator (112). Adaptor assembly (504) also has a proximalportion (510) that defines a cavity (512). In the illustrated example, acentral portion (514) is positioned in the cavity (512) and isconfigured to accept connector assembly (500). Adaptor assembly (504)includes conductive elements that enable electrical power to becommunicated from generator (112) to transducer assembly (102, 210) viareceptacle assembly (116), connector assembly (500), and cable (502). Insome versions, adaptor assembly (504) further includes conductiveelements that enable data to be communicated between generator (112) andinstrument (100, 200) via receptacle assembly (116), connector assembly(500), and cable (502). Adaptor assembly (504) may be furtherconstructed and operable in accordance with at least some of theteachings of U.S. Pat. No. 8,986,302, entitled “Surgical Generator forUltrasonic and Electrosurgical Devices,” issued Mar. 24, 2015, thedisclosure of which is incorporated by reference herein. Other suitableways in which adaptor assembly (504) may be constructed and operablewill be apparent to those of ordinary skill in the art in view of theteachings herein.

While adaptor assembly (114, 504) of the present example is shown asbeing interposed between connector assembly (500) and generator (112),it should be understood that variations of adaptor assembly (114, 504)may alternatively be located elsewhere. By way of example only, avariation of adaptor assembly (114, 504) may be located between cable(502) and transducer assembly (102, 210). Other suitable locations inwhich at least some of the components and/or functionality of adaptorassembly (114, 504) may be incorporated will be apparent to those ofordinary skill in the art in view of the teachings herein.

III. Methods for Managing Device Lifecycle

In some versions, a surgical instrument (100, 200) may include anelectrically erasable programmable read only memory (EEPROM) that storescertain operational data including, for example, a usage counter. Insome such versions, the EEPROM may be contained within the ultrasonictransducer assembly (102, 210). Alternatively, the EEPROM may becontained in the handle assembly (104) or body (204) of instrument (100,200); or elsewhere. The usage counter may be configured to track a totalnumber of uses of the surgical instrument (100, 200) (e.g., the numberof times transducer assembly (102, 210) was activated), the number ofsurgical procedures in which surgical instrument (100, 200) was used, atotal duration of usage of surgical instrument (100, 200), and/or otherusage related characteristics of the surgical instrument. While anEEPROM is used to provide a usage counter in the present example, itshould be understood that various kinds of memory elements may be usedto provide a usage counter.

When a surgical instrument (100, 200) is connected to a surgicalgenerator (112), generator (112) may be configured to provide power tosurgical instrument (100, 200) only if the usage counter of surgicalinstrument (100, 200) does not exceed a certain number of usages, totalduration of usage, number of activations, or the like. In this manner, amanufacturer may limit the number of uses of surgical instrument (100,200) from the factory, to prevent unlimited reuse of instrument (100,200) and the associated risks of mechanical failure due to overuse.While there may be advantages to providing a usage based lockout at thelevel of instrument (100, 200), it may also create inconveniences in thecase of refurbished devices, emergencies, equipment failure testing, andsimilar situations. Additionally, reprogramming and reconditioning ofthe EEPROM to allow continued use after an instrument (100, 200) expires(i.e., after usage of instrument (100, 200) has exceeded a threshold)may be inconvenient and expensive for the end user and manufacturer.

In addition to providing flexible compatibility between a variety ofgenerators (112) and surgical instruments (100, 200), adaptor assembly(114, 504) may allow the manufacturer to provide a limited EEPROMreprogramming capability to end users. In some versions, adaptorassembly (114, 504) may include an override device within the adaptorassembly (114, 504), which may comprise a memory and/or processor thatmay be used to reprogram an EEPROM within surgical instrument (100,200). When attached to a generator (112) through an adaptor assembly(114, 504), the override device will be placed in line with data andpower connections between generator (112) and surgical instrument (100,200) and may pass along data or information causing the EEPROM to beoverwritten without requiring that the EEPROM be removed from surgicalinstrument (100, 200) and reprogrammed or reconditioned manually.Various suitable structural components and control algorithms that maybe incorporated into adaptor assembly (114, 504) that may be used toprovide this capability of reprogramming an EEPROM in instrument (100,200) will be apparent to those of ordinary skill in the art in view ofthe teachings herein. Similarly, various suitable components and controlalgorithms that may be incorporated into generator (112) in order toprovide such operability through adaptor assembly (114, 504) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

FIG. 8 shows a flowchart of an exemplary set of steps that a systemcould perform to modify the operation of a connected surgical instrument(100, 200) via adaptor assembly (114, 504). When a surgical instrument(100, 200) is attached (block 800) to a generator (112) by way ofadaptor assembly (114, 504), one or more actions may occur dependingupon the configuration of the override device within adaptor assembly(114, 504). If the override device is configured to add additionaldevice uses to an EEPROM (block 802), when a connection between adaptorassembly (114, 504) and connector assembly (500) is established (block800), the override device may update an internal override counter (block804). The override counter may be used to prevent the override devicefrom being used an unlimited number of times. So, for example, when anoverride counter reaches a certain number it will be prevented fromadding uses (block 802) to further surgical instruments (100, 200).Additionally, the EEPROM of surgical instrument (100, 200) will receivea set of signals from the override device causing the usage counter tobe updated (block 806) and, in effect, reduce the detectable usage ofinstrument (100, 200) as perceived by generator (112).

As an example, suppose an instrument (100) was purchased in an unusedstate and contained an EEPROM with a usage counter initially showingzero uses. Instrument (100) is then used ten times during variousprocedures, and the usage counter now shows ten uses. When connected toan adaptor assembly (114, 504) that is configured to add additional usesto instrument (100), the usage counter may reduced back to zero (block806); or may be reduced by a set amount such as five uses, or any othernumber of desirable uses. Adaptor assembly (114, 504) itself in thisexample has an override counter of one. If a generator (112) isconfigured to place instrument (100) into a lockout mode after ten uses,instrument (100) will not function when the usage counter indicates tenuses have occurred. However, after the usage counter is decremented(804) by adaptor assembly (114, 504), generator (112) will detect thatinstrument (100) has been used less than ten times, and will allow anumber of additional usages until the usage counter reaches ten again.When used to modify the EEPROM (block 806), adaptor assembly (114, 504)override counter will be reduced to zero (804), so that if adaptorassembly (114, 504) is attached to a further surgical instrument (100,200), adaptor assembly (114, 504) will be unable to add uses (block802).

In some versions, the override device may be further configured tomaintain an internal mapping of surgical instruments (100, 200) thathave been modified so that a particular surgical instrument (100, 200)may only have its EEPROM updated (block 806) a single time. So, forexample, if a particular adaptor assembly (114, 504) is configured toallow five surgical instruments (100, 200) to have their EEPROM beupdated (block 806) to allow additional uses, adaptor assembly (114,504) may maintain an internal listing of the serial numbers of eachsurgical instrument (100, 200) that adaptor assembly (114, 504) is usedwith by pulling the unique identifier from the EEPROM as the EEPROM isupdated. In this manner, the manufacturer of adaptor assembly (114, 504)can ensure that adaptor assembly (114, 504) is used to enable usage offive different surgical instruments (100, 200), rather than being usedto enable a single surgical instrument (100, 200) to be used five timesand thereby potentially enabling dangerous overuse.

The lifecycle of new and reconditioned devices may be managed asdescribed above, or may, in addition or in the alternative, be managedin different ways. Some adaptor assemblies (114, 504) may be configuredto perform a factory reset (block 808) of a surgical instrument (100,200) that is attached (block 800) to adaptor assembly (115, 504). Thiswould function similarly to adding uses (block 802) but would revert theEEPROM of the attached instrument (100, 200) to its factory state (block812) and, in doing so, would reduce the instrument (100, 200) usagecounter to its factory state. The override device may be configured tomaintain an override counter and update the override counter (block 810)upon each factory reset to prevent unlimited reversions. The overridedevice may also be configured to maintain an internal mapping ofuniquely identified surgical instruments (100, 200) that have beenreverted in this manner, to prevent unlimited reversions of the sameinstrument (100, 200), which could result in dangerous overuse.

An additional use of the override device would be to allow infiniteusage (block 814) of surgical instrument (100, 200), completelyoverriding its EEPROM usage counter (block 816). This approach could beuseful in testing scenarios where a manufacturer or certifying agencymight want to test the boundaries of the performance of instrument (100,200) without being restrained by usage counter lockout. Yet another useof the override device would be to manage all additional usages with theoverride device itself rather than overwriting EEPROMs of surgicalinstruments (100, 200). This could be accomplished by configuring theoverride device of adaptor assembly (114, 504) to pair with a limitednumber of surgical instruments (100, 200) upon attachment (block 800)and maintain a list of each paired surgical instrument (100, 200) andthe number of additional uses that have been allowed (block 820). Inthis manner, the paired surgical instrument (100, 200) EEPROM is notchanged, but adaptor assembly (114, 504) itself is able to identify eachsurgical instrument (100, 200) that adaptor assembly (114, 504) has beenpaired with; and the number of additional uses that each pairedinstrument (100, 200) has been allowed.

Since the override device itself is managing the mapping (block 820),the EEPROM of the paired surgical instrument (100, 200) would beoverridden (816) and allowed to function so long as the managed mapping(820) allows for additional usages of the paired surgical instrument(100, 200). This could be advantageous where certain EEPROM have limitedrewrite capability or are prone to data corruption upon rewrite, forexample. Additionally, this feature could be used to enable a limitedcompatibility between a generator (112) from a first manufacturer and asurgical instrument (100, 200) from a second manufacturer where, forexample, the second manufacturer does not track device usage in themanner that generator (112) is expecting. For example, a surgicalinstrument (100, 200) from a second manufacturer may not store within anEEPROM the usage characteristics that a generator (112) from a firstmanufacturer will verify before allowing surgical instrument (100, 200)to operate. An adaptor assembly (114, 504) storing a device mapping(820) could allow a limited number of non-compliant surgical instruments(100, 200) to function despite not having the expected EEPROM usagecontents.

In some versions, EEPROM may be written with additional data upon anEEPROM update (block 806) or reversion (block 812). For example, arewrite flag may be set within the EEPROM upon an update (block 806) orreversion (block 812) indicating that the EEPROM has been rewritten oneor more times since its factory state. This rewrite flag may be detectedin future instances where an adaptor assembly (114, 504) is attached(block 800) and attempts to add uses (block 802) or perform a factoryreset (block 808) and prevent the operation from completing. This couldbe used to prevent unlimited reuse of particular instruments (100, 200),and could be used in additionally or alternatively with a record ofrewritten instruments (100, 200) maintained internally by the overridedevice.

In some versions, adaptor assembly (114, 504) and integrated overridedevice may be configured to communicate with an external system toassist in managing data. For example, adaptor assembly (114, 504) maycontain a wireless communication capability such as WiFi, may beintegrated with a wired communication capability such as Micro USB, ormay be paired with a docking device that itself integrates suchcommunication capability. As another merely illustrative example, suchcommunication capability may be incorporated into generator (112). Asthe override device is used to connect with surgical instruments (100,200), update (block 806) or revert EEPROM (block 812) or pair withdevices (block 818) and maintain usage mapping (block 820), it willcreate and store potentially useful data describing a variety of realworld usages of adaptor assembly (114, 504) and connected surgicalinstruments (100, 200).

For example, an adaptor assembly (114, 504) communicating with anexternal server could provide data identifying the particular serialnumbers of surgical instruments (100, 200) that adaptor assembly (114,504) has been attached with, surgical instruments (100, 200) that havehad an EEPROM updated or modified, times and dates of such occurrences,locations of such occurrences, and the like. Such information could beuseful in tracking a certain surgical instrument (100, 200) anddetermining if it has been used in a manner not recommended by themanufacturer (e.g., by updating the EEPROM multiple times), could trackmissing or stolen surgical instruments (100, 200), could detect when aparticular user may need to purchase additional surgical instruments(100, 200) or adaptor assemblies (114, 504), and other similarinformation. This could additionally provide opportunities to “recharge”an adaptor assembly (114, 504) remotely, where, for example, an adaptorassembly (114, 504) override counter has been reduced to zero. In such ascenario, an adaptor assembly (114, 504) could be connected to anexternal system and, based upon a transaction or other occurrence, haveits override counter reduced or incremented to allow additionaloverrides.

It should be understood that when use or uses of a surgical instrumentis discussed, such as adding uses (block 802) and allowing infinite uses(block 814), this could include both full usage of a surgical instrument(100, 200), as well as selective enablement of certain features of asurgical instrument (100, 200). For example, some versions of surgicalinstrument (100, 200) may provide a basic functionality and an advancedfunctionality. For instance, a basic functionality or mode of operationmay provide a sustained delivery of ultrasonic energy, at a consistentpower level, to tissue in response to actuation of buttons and/or otheruser input features of instrument (100, 200). An advanced functionalityor mode of operation may provide adaptive delivery of ultrasonic energyat a power level that varies in real time based on sensed tissueconditions (e.g., tissue temperature, tissue impedance, etc.). Wheresuch varying functionalities or modes of operation are available,adaptor (114) may be configured to modify the usage counter such thatonly the basic functionality is restored for a certain number of uses;or may be configured to modify the usage counter to restore basicfunctionality and at least some aspects of the advanced functionalityfor a certain number of total or individual uses between the two featuresets, while still preventing use of at least some other aspects of theadaptive functionality. This may be useful where, for example,reconditioning and reuse of devices may be determined to be safe for thebasic functionality of the device, while advanced or adaptive featuresmay only be verifiably safe with brand new surgical instruments (100,200). This may also be useful where, for example, a surgical instrument(100, 200) was not originally configured to allow a certainfunctionality, such as the adaptive cutting functionality, and it islater determined that the surgical instrument (100, 200) is able tosafely perform the adaptive cutting functionality but is unable to do sobecause the generator (112) determines that the surgical instrument(100, 200) lacks the configuration to support the functionality. In thisscenario, the adaptor (114) may modify the surgical instrument (100,200) EEPROM to support the functionality in question, or may overridecommunications between the surgical instrument (100, 200) and thegenerator (112) so that the functionality may be supported. Otherexamples of features of a surgical instrument (100, 200) being partiallyor fully enabled will be apparent in light of the disclosure herein.

FIG. 9 shows a flowchart of an exemplary set of steps that a systemcould perform to notify a user of a depleted surgical instrument (100,200). The steps in FIG. 9 may be performed in conjunction with orindependently of the adaptor assembly (114, 504) discussed above. When asurgical instrument (100, 200) is attached (block 900), generator (112)may access surgical instrument (100, 200) EEPROM and determine, basedupon a usage counter, whether surgical instrument (100, 200) is at ornear its final use before a usage based lockout mode is enabled (902).If the attached instrument (100, 200) is not at or near a final use(block 902), then no alert occurs (block 904) and operation is normal.If the attached instrument (100, 200) is at a final use (block 902),generator (112) may provide a preemptive warning via display (118) oranother device of generator (112). The preemptive warning may be avisual or audible indicator, and may in some cases provide a textual oraudible explanation.

When the use of instrument (100, 200) is complete (block 908), asindicated by the powering down or disconnection of instrument (100,200), instrument (100, 200) and/or generator (112) may perform one ormore additional actions to notify a user that the final use ofinstrument (100, 200) has occurred. These actions could include, forexample, displaying via generator (112) or a display of instrument (100,200) a notification indicating that the final use has occurred andinstrument (100, 200) has expired (block 910). Such a notification mayalso display a button or prompt on a touch screen display (e.g., ondisplay (118)) requiring that the user touch the button or otherwiseacknowledge the notification (block 912). Another action could includecausing an audible notification to emit from generator (112), surgicalinstrument (100, 200), or both. The audible warning could be anintermittent beep or tone, or could be an automated voice messageexplaining that surgical instrument (100, 200) is expired. Such a beep,tone, or voice could continue until an additional button of generator(112) or surgical instrument (100, 200) is actuated to indicate that thewarning has been acknowledged. Another action could include a visualwarning (block 916) such as an LED or other visual indicator ofgenerator (112) or surgical instrument (100, 200) lighting, flashing, orotherwise visually indicating that instrument (100, 200) has expired.The visual warning (block 916) could continue until the user presses abutton to acknowledge the warning.

The preemptive and subsequent warnings relating to surgical instrument(100, 200) usage and expiration may be useful to users of surgicalinstrument (100, 200) because it allows the user to account for theimpending expiration of surgical instrument (100, 200) rather thandiscovering that a surgical instrument (100, 200) has already expiredwhen it is presently needed. For example, without the described warning,a surgical instrument (100, 200) may be used for a surgical procedureand its usage counter may be incremented, resulting in the surgicalinstrument (100, 200) expiring at the end of the surgical procedure; butno expiration notice is provided when surgical instrument (100, 200) ispowered down or disconnected from the generator (112). Rather than beingdisposed of or placed in a storage area for expired devices, the expiredsurgical instrument (100, 200) might be taken to be sanitized andprepared for a subsequent surgical procedure. During a subsequentsurgical procedure, surgical instrument (100, 200) is connected to thegenerator (112), and only then does the user discover that surgicalinstrument (100, 200) has expired, requiring a delay in the procedurewhile a usable surgical instrument (100, 200) is located and prepared.

Configuring a generator (112) and/or surgical instrument (100, 200) toperform the steps of FIG. 9 resolves the inefficient and potentiallydangerous inability to appropriately react to expiration of aninstrument (100, 200). Supposing the same surgical instrument (100, 200)described above being used in a procedure for its final use before ausage counter causes it to enter lockout mode, when surgical instrument(100, 200) is attached to generator (112) it is determined that surgicalinstrument (100, 200) is on its final use (902). A notification may bedisplayed via the display (118) of the generator (112) indicating thatsurgical instrument (100, 200) has only one use remaining, and will thusbe expired after the present surgical procedure. After the surgicalprocedure, when surgical instrument (100, 200) is powered down ordisconnected from generator (112), generator (112) displays anadditional message or notification via display (118) explaining thatsurgical instrument (100, 200) is now expired and should be treatedappropriately. Generator (112) may continue to display this notificationand prevent further use until an acknowledgment is received (912) fromthe user that the expired surgical instrument (100, 200) has beenhandled appropriately. Additionally, an audible tone (914) or flashingLED (918) indicator may be activated on the surgical instrument (100,200) and continue after the device is powered down or disconnected fromgenerator (112). The audible tone or flashing LED may continue untilmanually acknowledged or until a power supply, such as a battery orcapacitor, within the surgical instrument (100, 200) is drained. In thismanner, users of a soon to be expired surgical instrument (100, 200) aregiven several opportunities, some requiring action, to acknowledge thatsurgical instrument (100, 200) has expired and avoid wasteful postprocedure activities with surgical instrument (100, 200), as well asavoid potentially dangerous reliance on an expired surgical instrument(100, 200) during subsequent procedures.

FIGS. 3 and 4 show exemplary interfaces and steps that could beperformed to provide the notification functionality described above inthe context of FIG. 9 . Referring to FIG. 3 , display (118) of generator(112) may initially show an operation interface (300) with informationand controls for normal operation of generator (112) and surgicalinstrument (100, 200) while surgical instrument (100, 200) is attachedto generator (112). When surgical instrument (100, 200) is unplugged(block 302) from generator (112), generator (112) will examine data fromthe EEPROM usage counter of surgical instrument (100, 200) and determineif it is now expired (block 304). If the generator (112) determines thatthe recently removed surgical instrument (100, 200) is expired (block304), generator (112) will generate an interface notification viadisplay (118) appropriate for surgical instrument (100, 200) that hasexpired.

For example, in the case of instrument (200), transducer assembly (210)is configured to be re-used a certain number of times; while the rest ofinstrument (200) is configured to only be used once (or some othernumber of times). Display (118) shows a notification (306) indicatingthat instrument (200) has expired and advising the operator to disposeof or replace transducer assembly (210). This notification (306)includes a graphical representation of transducer assembly (210). Insome versions, different portions of instrument (200) are capable ofbeing reused a different number of times. In such versions, display(118) may provide a notification (306) with a graphical representationof the particular component that has reached its maximum number of uses.Display (118) may also provide text to accompany the graphicalrepresentation, with the text advising the user that the expiredcomponent has reached its maximum number of uses; and instructing theuser to replace the expired component.

Similarly, in the case of instrument (100), transducer assembly (102) isconfigured to be re-used a certain number of times; while the rest ofinstrument (100) is configured to only be used once (or some othernumber of times). Display (118) shows a notification (308) indicatingthat instrument (100) has expired and advising the operator to disposeof or replace transducer assembly (102). This notification (308)includes a graphical representation of transducer assembly (102). Insome versions, different portions of instrument (100) are capable ofbeing reused a different number of times. In such versions, display(118) may provide a notification (308) with a graphical representationof the particular component that has reached its maximum number of uses.Display (118) may also provide text to accompany the graphicalrepresentation, with the text advising the user that the expiredcomponent has reached its maximum number of uses; and instructing theuser to replace the expired component.

Notification (306, 308) may also have a prompt such as an “OK” or “NEXT”button that requires a user to interact with display (118) or generator(112) before a subsequent use in order to confirm (310) that the userhas received the expired device notification (306, 308). Onceconfirmation is received (block 310), generator (112) may display anon-operation interface (312) indicating that generator (112) is readyfor a subsequent use with a different surgical instrument (100, 200).Operating in the manner described in the context of FIG. 3 , when asurgical instrument (100, 200) expires after use with a generator (112),generator (112) will require a user acknowledgment that surgicalinstrument (100, 200) is now expired before returning to an operationalstate.

Referring to FIG. 4 , display (118) of generator (112) may initiallyshow a non-operation interface (400) immediately before shut down ofgenerator (112). When generator (112) is powered off (block 402),generator (112) will determine if any surgical instrument (100, 200) wasrecently used that is now expired (404). This may be done by examiningthe generator's (112) records of instruments (100, 200) attached sincegenerator (112) was last powered on; and whether the EEPROM of any ofthose instruments (100, 200) indicate that the instrument (100, 200)only had one usage remaining. If any instruments (100, 200) were usedthat are now expired (block 404), generator (112) may display anappropriate notification describing instrument (100, 200) or componentthat is now expired. For example, if instrument (200) was used and isnow expired, display (118) may show a notification (406) similar tonotification (306) described above. If instrument (100) was used and isnow expired, the display (118) may show a notification (408) similar tonotification (308) described above.

The notification interfaces (406, 408) may also include a button orprompt to interact with display (118) to acknowledge the notification;and generator (112) may delay shutting down until a confirmation isreceived (block 410) from the user. Once the confirmation is received(block 410), generator (112) may display a shut down interface (412).Operating in the manner described above in the context of FIG. 4 , whena surgical instrument (100, 200) expires after use with a generator(112), generator (112) will require a user acknowledgment thatinstrument (100, 200) is now expired before shutting down.

IV. Exemplary Combinations

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

Example 1

An apparatus comprising: (a) a surgical generator comprising aninstrument receptacle; and (b) an adaptor, the adaptor comprising afirst end, a second end, and an override chip, wherein the first end ofthe adaptor is shaped to fit the instrument receptacle, wherein thesecond end of the adapter is shaped to fit a surgical instrumentconnector; wherein the surgical generator is configured to, upon beingconnected to a surgical instrument via the adaptor, receive a set ofusage data from a memory of the surgical instrument; wherein thesurgical generator is further configured to prevent operation of thesurgical instrument based upon the set of usage data; wherein theoverride chip is configured to modify the set of usage data before it isreceived by the surgical generator.

Example 2

The apparatus of Example 1, wherein the override chip is configured tomodify the set of usage data by modifying the contents of the memory ofthe surgical instrument.

Example 3

The apparatus of any one or more of Examples 1 through 2, wherein theoverride chip is configured to modify the set of usage data by creatingan override set of usage data, and wherein the override chip isconfigured to replace the set of usage data with the override set ofusage data before the set it is received by the surgical generator.

Example 4

The apparatus of any one or more of Examples 1 through 3, wherein theset of usage data from the memory comprises a usage counter, wherein theusage counter indicates an amount of usage of the surgical instrumentsince its manufacture.

Example 5

The apparatus of Example 4, wherein the override chip is configured tomodify the set of usage data by reducing the amount of usage of thesurgical instrument.

Example 6

The apparatus of any one or more of Examples 1 through 5, wherein theoverride chip stores a set of override data, wherein the override chipis configured to modify the set of override data in response to the setof usage data being modified.

Example 7

The apparatus of Example 6, wherein the set of override data comprises:(i) an override counter indicating the number of times the override chiphas been used to modify the set of usage data, and (ii) an override mapuniquely identifying one or more surgical instruments whose usage datahas been modified by the override chip.

Example 8

The apparatus of Example 7, wherein the override chip is configured toonly modify the set of usage data when the override counter does notexceed a configured limit.

Example 9

The apparatus of any one or more of Examples 1 through 8, wherein theoverride set of usage data is configured to prevent the surgicalgenerator from preventing operation of the surgical instrument.

Example 10

The apparatus of any one or more of Examples 1 through 9, wherein theoverride chip is configured to modify the set of usage data by adding anoverride flag, wherein the override flag indicates that the memory hasbeen previously modified, and wherein the override chip is furtherconfigured to only modify the memory when the override flag is notpresent.

Example 11

The apparatus of any one or more of Examples 1 through 10, wherein thesurgical generator is manufactured by a first manufacturer, wherein thesurgical instrument is manufactured by a second manufacturer, andwherein the surgical instrument is only operable with the surgicalgenerator after the set of usage data has been modified.

Example 12

The apparatus of any one or more of Examples 1 through 11, furthercomprising an external server, wherein the adaptor comprises acommunication port in communication with the external server, whereinthe adaptor is configured to send a set of override data to the externalserver.

Example 13

The apparatus of any one or more of Examples 1 through 12, wherein theset of usage data comprises a plurality of sets of feature data, whereina set of feature data of the plurality of sets of feature data indicatesthe number of times a particular feature of the surgical instrument hasbeen used, wherein the override chip is configured to modify the set ofusage data before it is received by the surgical generator by modifyingthe set of feature data to allow for additional use of the particularfeature.

Example 14

An apparatus comprising: (a) a surgical generator comprising aninstrument receptacle and a display; and (b) a surgical instrumentcomprising a generator connection, the generator connection adapted tobe connected to the instrument receptacle; wherein the surgicalgenerator is configured to, upon being connected to a surgicalinstrument, receive a set of usage data from a memory of the surgicalinstrument; wherein the surgical generator is configured to determine ifthe set of usage data indicates that the surgical instrument will becomeinoperable after being used for a present procedure; wherein thesurgical generator is configured to receive a signal indicating that thesurgical instrument is no longer in use; wherein the surgical generatoris configured to, in response to a determination that the surgicalinstrument will become inoperable and the signal indicating that thesurgical instrument is no longer in use, provide a notification that thedevice is inoperable for subsequent uses.

Example 15

The apparatus of Example 14, wherein the notification that the device isinoperable for subsequent uses comprises one or more of: (i) a textnotification via the display, (ii) a light emitting from a lightindicator of the surgical instrument, and (iii) a tone emitting from aspeaker of the surgical instrument.

Example 16

The apparatus of any one or more of Examples 14 through 15, wherein thenotification that the device is inoperable for subsequent uses comprisesan acknowledgment prompt, and wherein the surgical generator isconfigured to prevent normal operation until a signal is receivedindicating that a user has acknowledged the acknowledgment prompt.

Example 17

The apparatus of Example 16, wherein the signal indicating that thesurgical instrument is no longer in use is caused by the disconnectionof the surgical generator connection from the instrument receptacle.

Example 18

The apparatus of any one or more of Examples 16 through 17, wherein thesignal indicating that the surgical instrument is no longer in use iscaused by a user interaction with the surgical generator causing thesurgical generator to be powered off.

Example 19

An apparatus comprising: (a) a surgical generator comprising aninstrument receptacle and a display; (b) a surgical instrumentcomprising a generator connection; and (c) an adaptor, the adaptorcomprising a first end, a second end, and an override chip, wherein thefirst end of the adaptor is shaped to fit the instrument receptacle,wherein the second end of the adapter is shaped to fit the generatorconnection, wherein the surgical generator is configured to connect tothe surgical instrument via the adaptor; wherein the surgical generatoris further configured to, upon being connected to the surgicalinstrument, receive a set of usage data from a memory of the surgicalinstrument; wherein the surgical generator is further configured todetermine if the set of usage data indicates that the surgicalinstrument will become inoperable after being used for a presentprocedure; wherein the surgical generator is further configured toreceive a signal indicating that the surgical instrument is no longer inuse; wherein the surgical generator is further configured to, inresponse to a determination that the surgical instrument will becomeinoperable and the signal indicating that the surgical instrument is nolonger in use, provide a notification that the device is inoperable forsubsequent uses; wherein the adaptor is operable to modify the set ofusage data on the memory and reduce a usage indicator of the set ofusage data; and wherein the surgical instrument is configured to becomeoperable in response to the usage indicator being reduced by theadaptor.

Example 20

The apparatus of Example 19, further comprising a plurality ofreconditioned surgical instruments, each of the plurality ofreconditioned surgical instruments storing an instrument identifier anda reconditioned device usage data, wherein the adaptor is configured tostore a set of instrument identifiers, and wherein the adaptor isconfigured to modify a reconditioned device usage data only when theinstrument identifier is present in the set of instrument identifiers.

V. Miscellaneous

It should be understood that any of the versions of instrumentsdescribed herein may include various other features in addition to or inlieu of those described above. By way of example only, any of theinstruments described herein may also include one or more of the variousfeatures disclosed in any of the various references that areincorporated by reference herein. It should also be understood that theteachings herein may be readily applied to any of the instrumentsdescribed in any of the other references cited herein, such that theteachings herein may be readily combined with the teachings of any ofthe references cited herein in numerous ways. Other types of instrumentsinto which the teachings herein may be incorporated will be apparent tothose of ordinary skill in the art.

It should also be understood that any ranges of values referred toherein should be read to include the upper and lower boundaries of suchranges. For instance, a range expressed as ranging “betweenapproximately 1.0 inches and approximately 1.5 inches” should be read toinclude approximately 1.0 inches and approximately 1.5 inches, inaddition to including the values between those upper and lowerboundaries.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Versions of the devices described above may have application inconventional medical treatments and procedures conducted by a medicalprofessional, as well as application in robotic-assisted medicaltreatments and procedures. By way of example only, various teachingsherein may be readily incorporated into a robotic surgical system suchas the DAVINCI™ system by Intuitive Surgical, Inc., of Sunnyvale, Calif.Similarly, those of ordinary skill in the art will recognize thatvarious teachings herein may be readily combined with various teachingsof U.S. Pat. No. 6,783,524, entitled “Robotic Surgical Tool withUltrasound Cauterizing and Cutting Instrument,” published Aug. 31, 2004,the disclosure of which is incorporated by reference herein.

Versions described above may be designed to be disposed of after asingle use, or they can be designed to be used multiple times. Versionsmay, in either or both cases, be reconditioned for reuse after at leastone use. Reconditioning may include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, someversions of the device may be disassembled, and any number of theparticular pieces or parts of the device may be selectively replaced orremoved in any combination. Upon cleaning and/or replacement ofparticular parts, some versions of the device may be reassembled forsubsequent use either at a reconditioning facility, or by an operatorimmediately prior to a procedure. Those skilled in the art willappreciate that reconditioning of a device may utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

By way of example only, versions described herein may be sterilizedbefore and/or after a procedure. In one sterilization technique, thedevice is placed in a closed and sealed container, such as a plastic orTYVEK bag. The container and device may then be placed in a field ofradiation that can penetrate the container, such as gamma radiation,x-rays, or high-energy electrons. The radiation may kill bacteria on thedevice and in the container. The sterilized device may then be stored inthe sterile container for later use. A device may also be sterilizedusing any other technique known in the art, including but not limited tobeta or gamma radiation, ethylene oxide, or steam.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

We claim:
 1. An apparatus, comprising: (a) a surgical generatorcomprising an instrument receptacle and a display; and (b) a surgicalinstrument comprising a generator connection and an instrumentindicator, the generator connection adapted to be connected to theinstrument receptacle, wherein the surgical generator is configured to,upon being connected to the surgical instrument, receive a set of usagedata from a memory of the surgical instrument, wherein the surgicalgenerator is configured to determine if the set of usage data indicatesthat the surgical instrument will become inoperable after being used fora present procedure, wherein the surgical generator is configured toreceive a signal indicating that the surgical instrument is no longer inuse, wherein the surgical generator is configured to, in response to adetermination that the surgical instrument will become inoperable andthe signal indicating that the surgical instrument is no longer in use,provide a notification that the surgical instrument is inoperable forsubsequent uses, and wherein the instrument indicator is configured toactivate in response to the determination that the surgical instrumentwill become inoperable and the signal indicating that the surgicalinstrument is no longer in use.
 2. The apparatus of claim 1, wherein thenotification that the surgical instrument is inoperable for subsequentuses comprises one or more of: (i) a text notification via the display,(ii) a light emitting from a light indicator of the surgical instrument,and (iii) a tone emitting from a speaker of the surgical instrument. 3.The apparatus of claim 1, wherein the notification that the surgicalinstrument is inoperable for subsequent uses comprises an acknowledgmentprompt, and wherein the surgical generator is configured to preventnormal operation until a signal is received indicating that a user hasacknowledged the acknowledgment prompt.
 4. The apparatus of claim 3,wherein the signal indicating that the surgical instrument is no longerin use is caused by disconnecting the generator connection from theinstrument receptacle.
 5. The apparatus of claim 3, wherein the signalindicating that the surgical instrument is no longer in use is caused bya user interaction with the surgical generator causing the surgicalgenerator to be powered off.
 6. The apparatus of claim 1, wherein thesurgical instrument further comprises an internal power source and theinstrument indicator includes a light indicator, wherein the lightindicator is configured to, once activated, be permanently activated andemit light until the internal power source is expended.
 7. The apparatusof claim 1, wherein the surgical instrument further comprises aninternal power source and the instrument indicator includes a soundindicator, wherein the sound indicator is configured to, once activated,be permanently activated and emit audible tones until the internal powersource is expended.
 8. An apparatus, comprising: (a) a surgicalgenerator comprising an instrument receptacle and a display; (b) asurgical instrument comprising a generator connection and a memory; and(c) an adaptor, the adaptor comprising a first end, a second end, and anoverride chip, wherein the first end of the adaptor is shaped to fit theinstrument receptacle, wherein the second end of the adapter is shapedto fit the generator connection, wherein the surgical generator isconfigured to connect to the surgical instrument via the adaptor,wherein the surgical generator is further configured to, upon beingconnected to the surgical instrument, receive a set of usage data fromthe memory of the surgical instrument, wherein the surgical generator isfurther configured to determine if the set of usage data indicates thatthe surgical instrument will become inoperable after being used for apresent procedure, wherein the surgical generator is further configuredto receive a signal indicating that the surgical instrument is no longerin use, wherein the surgical generator is further configured to, inresponse to a determination that the surgical instrument will becomeinoperable and the signal indicating that the surgical instrument is nolonger in use, provide a notification that the surgical instrument isinoperable for subsequent uses, wherein the adaptor is configured tomodify the set of usage data on the memory and reduce a usage indicatorof the set of usage data, and wherein the surgical instrument isconfigured to become operable in response to the usage indicator beingreduced by the adaptor.
 9. The apparatus of claim 8, further comprisinga plurality of reconditioned surgical instruments, wherein each of theplurality of reconditioned surgical instruments respectively stores aninstrument identifiers thereon and a reconditioned device usage data,wherein the adaptor is configured to store a set of instrumentidentifiers, and wherein the adaptor is configured to modify therespective reconditioned device usage data only when the respectiveinstrument identifier is present in the set of instrument identifiers.10. The apparatus of claim 9, wherein the adaptor is configured tomodify the set of usage data on the memory and reduce the usageindicator of the set of usage data to allow the surgical instrument tobe usable for one future procedure after use for the present procedure.11. The apparatus of claim 9, wherein the adaptor is configured tomodify the set of usage data on the memory and reduce the usageindicator of the set of usage data to allow the surgical instrument tobe usable for an unlimited number of future procedures after use for thepresent procedure.
 12. The apparatus of claim 9, wherein the adaptor isconfigured to: (i) modify the set of usage data on the memory and reducethe usage indicator of the set of usage data to reset the memory to afactory state, (ii) store an override counter indicating a number ofsurgical instrument memories that have been reset to the factory state,and (iii) allow a limited number of factory resets based on the overridecounter.
 13. The apparatus of claim 9, wherein the adaptor is configuredto: (i) modify the set of usage data on the memory and reduce the usageindicator of the set of usage data to reset the memory to a factorystate, (ii) store a device mapping that uniquely identifies the surgicalinstrument, and (iii) prevent modification of usage data on a memory ofany surgical instrument that is already uniquely identified in thedevice mapping.
 14. A method of providing a notification from a surgicalinstrument, comprising: (a) connecting the surgical instrument to asurgical generator; (b) at the surgical generator, receiving a set ofusage data from a memory of the surgical instrument; (c) determining ifthe set of usage data indicates that the surgical instrument will becomeinoperable after being used for a present procedure; (d) receiving asignal indicating that the surgical instrument is no longer in use; (e)in response to a determination that the surgical instrument will becomeinoperable and the signal indicating that the surgical instrument is nolonger in use, providing the notification that the surgical instrumentis inoperable for subsequent uses; and (f) automatically activating ausability indicator on the surgical instrument to indicate that thesurgical instrument is inoperable for subsequent uses.
 15. The method ofclaim 14, further comprising: (a) displaying an acknowledgment promptvia a display with the notification that the surgical instrument isinoperable for subsequent uses; and (b) preventing further use of thesurgical generator with any surgical instrument until a user interactswith the acknowledgement prompt.
 16. The method of claim 15, wherein thesignal indicating that the surgical instrument is no longer in use iscaused by a loss of communication between the surgical generator and thesurgical instrument as a result of: (i) the surgical generator beingdisconnected from the surgical instrument, or (ii) a loss of externalpower to the surgical generator.
 17. The method of claim 14, whereinproviding the notification further includes providing the notificationvia a display of the surgical generator that the surgical instrument isinoperable for subsequent uses, and wherein automatically activating theusability indicator further includes automatically activating theusability indicator on the surgical instrument to indicate that thesurgical instrument is inoperable for subsequent uses when providing thenotification via the display.
 18. The method of claim 17, furthercomprising, after completion of the present procedure: (a) disposing ofthe surgical instrument if the usability indicator is activated; and (b)sterilizing the surgical instrument if the usability indicator is notactivated.
 19. The method of claim 17, wherein activating the usabilityindicator comprises activating a sound indicator of the surgicalinstrument to emit audible tones until an internal power source of thesurgical instrument is expended.
 20. The method of claim 17, whereinactivating the usability indicator comprises activating a lightindicator of the surgical instrument to emit light until an internalpower source of the surgical instrument is expended.